Plunger Stopper Movement Under Low Pressure Whitepaper

Plunger Stopper Movement Under Low Pressure Whitepaper

Updated June 2026
Maintaining the integrity of pre-filled syringes throughout storage and distribution is essential to ensuring product performance. Changes in pressure during air transport can cause plunger stopper movement, which may affect dose delivery or compromise the sterile barrier if movement exceeds acceptable limits.

This whitepaper explains how plunger stopper movement testing can be used during product development and design verification testing to assess device performance under low-pressure conditions. It outlines the factors that influence stopper movement, describes typical test methods based on ASTM D6653, and reviews the standards that support this work.

What is included in the whitepaper:

  • Why plunger stopper movement testing is important for pre-filled syringes
  • How pressure changes during air transport can affect device integrity and performance
  • Which variables influence plunger stopper movement, including pressure, temperature, headspace volume, and component interactions
  • How test conditions can be tailored to simulate anticipated distribution routes
  • The typical procedure used to evaluate plunger stopper movement under vacuum conditions
  • Which regulatory standards and industry guidance documents are commonly applied, including ASTM, USP, and ISO requirements
  • How bespoke test methods can be developed to support product development and design verification programs

Download the Whitepaper below:

Smithers-Plunger-Stopper-Movement_2022
Smithers-Plunger-Stopper-Movement_2022

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